MAUDE Adverse Event Report: ENZTEC LIMITED CONDUIT LLIF SQUID INSERTER; SPINAL INSERTER

Model Number	LET30290T
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact date of surgery unknown.Event occurred outside the united states but product is available in us.
Event or Problem Description
During use of the instrument, the implant rotated unexpectedly anteriorly in the disc space such that the implant had to be re-inserted during the same procedure.There was no damage to the implant or instrument reported, and the device mechanism does not appear to have malfunctioned.There were no post-operative complications reported.Incident occurred in switzerland.

• Brand Name: CONDUIT LLIF SQUID INSERTER
• Common Device Name: SPINAL INSERTER
• Manufacturer (Section D): ENZTEC LIMITED; 3/17 print place; middleton; christchurch, canterbury 8024 ; NZ 8024
• Manufacturer (Section G): ENZTEC LIMITED; 3/17 print place; middleton; christchurch, canterbury 8024 ; NZ 8024
• Manufacturer Contact: kate moorhead ; 3/17 print place; middleton; christchurch, 8024 ; NZ 8024
• MDR Report Key: 17077030
• Report Number: 3004641308-2022-00002
• Device Sequence Number: 6468809
• Product Code: MAX
• UDI-Device Identifier: 09421028116459
• UDI-Public: 09421028116459
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K220449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LET30290T
• Device Catalogue Number: LET30290T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONDUIT LLIF SQUID BLADE - 22MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown